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Clinical Trials/EUCTR2011-004868-30-SE
EUCTR2011-004868-30-SEActive, not recruitingPhase 1

AN INTERNATIONAL PROSPECTIVE TRIAL ON MEDULLOBLASTOMA (MB) IN CHILDREN OLDER THAN 3 TO 5 YEARS WITH WNT BIOLOGICAL PROFILE (PNET 5 MB – LR and PNET 5 MB – WNT-HR), AVERAGE-RISK BIOLOGICAL PROFILE (PNET 5 MB -SR), OR TP53 MUTATION AND REGISTRY FOR MB OCCURRING IN THE CONTEXT OF GENETIC PREDISPOSITIO

niversity Medical Center Hamburg-Eppendorf0 sites410 target enrollmentStarted: May 22, 2015Last updated:
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Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
410
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • •General inclusion criteria all studies
  • •Submission of high quality biological material incl. fresh frozen tumour samples and blood
  • •Liver, renal, haematological function = 3x ULN
  • •Central pathology review, central molecular diagnosis of genetically defined subgroup, and central MRI mandatory
  • •Cytospin of lumbar CSF
  • •Written informed consent
  • •National and local ethical committee approval
  • •Common inclusion criteria LR, SR, WNT-HR
  • •No prior therapy for medulloblastoma (MB) other than surgery
  • •Radiotherapy aiming to start no more than 28 days after surgery. Foreseeable inability to start radiotherapy within 40 days after surgery renders patients ineligible for the study
  • •Inclusion of patients is not possible later than 40 days after first tumour surgery, or after start of radiotherapy
  • •No significant sensineural hearing deficit
  • •No identified germline APC, PTCH, SUFU, TP53, PALB2, or BRCA2 gene alteration. No unrefuted clinical suspect for patient or familial APC-associated polyposis conditions, biallelic mismatch repair syndrome, Li Fraumeni Syndrome, Gorlin Snydrome, Fanconi anaemia, or other hereditary condition that affects tolerance of antitumour treatment, or may prone to secondary tumours
  • •No other medical contraindication to radiotherapy or chemotherapy
  • •Specific inclusion criteria LR
  • •Age at diagnosis >3-5 and <16 years
  • •MB, WNT-activated; histologic subtypes: MB, classic and desmoplastic/nodular
  • •Clinically standard -risk MB, defined as total or near total surgical resection with less than or equal to 1.5 cm2 of residual tumour on early post-operative MRI, without and with contrast, on central review; no CNS metastasis on MRI on central review; no tumour cells on the cytospin of lumbar CSF, no clinical evidence of extra-CNS metastasis; Patients with a reduction of postoperative residual tumour through second surgery to less than or equal to 1.5 cm2 are eligible, if timeline for start of radiotherapy can be kept
  • •No amplification of MYC or MYCN
  • •Low-risk biological profile, defined as presence of ß-catenin mutation resulting in WNT activation
  • •Specific inclusion criteria SR-study
  • •Age at diagnosis >3-5 and <22 years
  • •MB, SHH-activated and TP53-wildtype; MB, non-WNT/non-SHH; MB, group 3; MB, group 4; Histologic subtype: MB, classic and desmoplastic/nodular
  • •Clinically standard-risk, defined as total or near total surgical resection with less than or equal to 1.5 cm2 of residual tumour on early post-operative MRI, without and with contrast, on central review; no CNS metastasis on MRI on central review; no tumour cells on the cytospin of lumbar CSF; no clinical evidence of extra-CNS metastasis; Patients with a reduction of postoperative residual tumour through second surgery to less than or equal to 1.5 cm2 are eligible, if timeline for start of radiotherapy can be kept
  • •No amplification of MYC or MYCN; MYCN amplification allowed for patients with group 4 MB
  • •WNT-subgroup negativity is prerequisite: WNT-negative tumours are defined by ß-catenin nuclear immuno-negativity by IHC, and the absence of ß-catenin mutation
  • •For patients wit

Exclusion Criteria

  • •Exclusion criteria LR
  • •a) One of the inclusion criteria is lacking;
  • •b) Brainstem or supratentorial embryonal tumour;
  • •c) Atypical teratoid rhabdoid tumour;
  • •d) Medulloepithelioma, embryonal tumour with multi-layered rosettes.
  • •e) Large cell/anaplastic medulloblastoma, or medulloblastoma with extensive nodularity (MBEN), confirmed on central pathological review.
  • •f) Unfavourable or undeterminable biological profile, defined as amplification of MYC or MYCN, or WNT subgroup status not determinable.
  • •g) Metastatic medulloblastoma (on CNS MRI and/or positive cytospin of postoperative lumbar CSF);
  • •h) Patient previously treated for a brain tumour or any type of malignant disease;
  • •i) identified germline APC, PTCH, SUFU, TP53, PALB2, or BRCA2 gene alteration. Unrefuted clinical suspect for patient or familial APC-associated polyposis conditions, biallelic mismatch repair syndrome, Li Fraumeni Syndrome, Gorlin Snydrome, Fanconi anaemia, or other hereditary condition that affects tolerance of antitumour treatment, or may prone to secondary tumours
  • •j) identified somatic TP53 mutation
  • •k) Patients who are pregnant;
  • •l) Female patients who are sexually active and not taking reliable contraception;
  • •m) Patients who cannot be regularly followed up due to psychological, social, familial or geographic reasons;
  • •n) Patients in whom non-compliance with toxicity management guidelines can be expected.
  • •Exclusion criteria SR
  • •a) One of the inclusion criteria is lacking;
  • •b) Brainstem or supratentorial embryonal tumour;
  • •c) Atypical teratoid rhabdoid tumour;
  • •d) Medulloepithelioma, embryonal tumour with multi-layered rosettes;
  • •e) Large-cell medulloblastoma, anaplastic medulloblastoma, or medulloblastoma with extensive nodularity (MBEN), confirmed on central pathological review;
  • •f) Unfavourable or undeterminable biological profile, defined as amplification of MYC or MYCN, or WNT subgroup status not determinable, MYCN amplification allowed for patients with group 4 medulloblastoma;
  • •g) Metastatic medulloblastoma (on CNS MRI and/or positive cytospin of postoperative lumbar CSF);
  • •h) Patient previously treated for a brain tumour or any type of malignant disease;
  • •i) identified germline APC, PTCH, SUFU, TP53, PALB2, or BRCA2 gene alteration. Unrefuted clinical suspect for patient or familial APC-associated polyposis conditions, biallelic mismatch repair syndrome, Li Fraumeni Syndrome, Gorlin Snydrome, Fanconi anemia, or other hereditary condition that affects tolerance of antitumour treatment, or may prone to secondary tumours
  • •j) identified somatic TP53 mutation
  • •k) Patients who are pregnant;
  • •l) Female patients who are sexually active and not taking reliable contraception;
  • •m) Patients who cannot be regularly followed up due to psychological, social, familial or geographic reasons;
  • •n) Patients in whom non-compliance with toxicity management guidelines can be expected.
  • •Exclusion criteria WNT-HR
  • •a) One of the inclusion criteria is lacking.
  • •b) Brainstem or supratento

Investigators

Sponsor
niversity Medical Center Hamburg-Eppendorf

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